FDA gives Johnson & Johnson's Erleada a quick push over the finish line with first-ever nonmetastatic prostate cancer nod

Johnson & Johnson is fighting a patent decision that would open up its older prostate cancer drug Zytiga to early generic competition. (J&J)

Johnson & Johnson just got a head start over Pfizer and Astellas in nonmetastatic prostate cancer. J&J’s new drug apalutamide won FDA approval months ahead of its scheduled decision date, and it’s now ready to scoop up market share before its rivals win a new, similar indication for their treatment, Xtandi.

Now known as Erleada, apalutamide is the first therapy to win approval for nonmetastatic prostate cancer, the FDA said, and the first to get a green light based on metastasis-free survival numbers. It’s also J&J’s follow-up to its blockbuster prostate cancer drug Zytiga, which scored a few approval firsts of its own but now faces an earlier-than-expected battle against generics later this year.

Speaking of battles, Erleada comes to the market with data showing “a robust effect” on metastasis-free survival, Richard Pazdur, M.D., chief of the FDA’s Office of Hematology and Oncology Products, said in a statement on Wednesday.

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It’s data that was released in detail just last week at ASCO’s Genitourinary Cancers Symposium, the same meeting where similar Xtandi data made its debut. In a trial called Spartan, Erleada delivered 40.5 metastasis-free months, a 24.3-month improvement over current therapy.

Xtandi’s results in its Prosper trial didn't match up exactly—and true comparisons are only possible in head-to-head clinical trials—but they were close. The Pfizer-Astellas drug, added to hormonal therapy, held off metastasis by 36.6 months at the median, a 21.9-month improvement over hormonal treatments alone.

RELATED: The top 15 best-selling cancer drugs in 2022 - Xtandi

“We recognize that cross-trial comparisons are fraught with issues, but Spartan and Prosper in our view essentially delivered identical outcomes,” Barclays analyst Geoff Meacham, Ph.D., wrote in a note on Monday. His firm predicts that Erleada can peak at $1.3 billion, well within blockbuster territory.

That’s not as much as Zytiga has delivered; the drug brought in $2.5 billion last year. But as Barclays noted, “commercial execution [is] the key to [the] next leg of growth” not only for Erleada but also for Xtandi. And with its early approval in hand, J&J can get going on promoting its drug to doctors well ahead of Pfizer and Astellas.

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